Decision places AppliedVR's flagship product RelieVRx™ in an existing benefit category, providing a critical next step for securing public and commercial health insurance coverage.
LOS ANGELES, March 21, 2023 /PRNewswire/ -- AppliedVR, an immersive therapeutics (ITx) pioneer advancing a novel approach to medicine, today announced that the Centers for Medicare and Medicaid Services (CMS) established a unique Healthcare Common Procedure Coding System (HCPCS) Level II code (E1905) for its flagship product, the RelieVRx program.
Defined as a virtual reality (VR) cognitive behavioral therapy (CBT) device that includes pre-programmed therapy software, CMS' coding decision categorizes the RelieVRx program as durable medical equipment (DME), making it the first ITx or digital therapeutic (DTx) to be placed in an existing benefit category. The RelieVRx program had to meet all five of the agency's requirements to be categorized as DME, a distinction that allows the solution to have a clearer pathway for securing Medicare coverage eligibility, which can influence commercial coverage more broadly.
In the official determination letter, CMS explained its decision by stating: "The medical software and the device on which it is housed are so integral to each other that we consider them to be one whole device, not software and a separate device."
This news marks a major milestone for AppliedVR and for millions of Americans experiencing chronic low back pain (CLBP) and their providers. AppliedVR will now work directly with CMS to establish the payment rate, as the company also continues to ready itself for broader market launch across the U.S.
"It's finally time to more fully embrace ITx and move toward its use becoming more towards standard of care rather than a 'one off' niche solution in the treatment of chronic lower back pain, for example. We envision Immersive Therapeutics as a future alternative to a lifetime of pills or costly surgeries. Enabling broad coverage for the RelieVRx program will deliver a powerful, yet affordable and scalable digital solution for millions of people," said Matthew Stoudt, co-founder and CEO of AppliedVR. "We're incredibly grateful to our regulatory partners, including CMS and the FDA, for their recognition and ongoing collaboration."
Chronic pain costs the U.S. an estimated $635 billion each year and is a major contributing factor driving America's opioid crisis. Approximately 8% of American adults – or 16 million people – experience CLBP alone, and it's a leading cause of disability.
The RelieVRx program previously became the first VR-based therapeutic to receive FDA authorization to treat CLBP. It provides an eight-week adjunctive treatment based on cognitive behavioral therapy skills and other evidence-based behavioral methods, and has been shown in clinical studies to produce durable effects on the severity of many known pain indicators.
Today's news also represents another significant achievement for AppliedVR over the past few months. The company was recently awarded a contract through the Veterans Health Administration's Innovation Ecosystem to provide covered access to RelieVRx across multiple of its sites. Additionally, AppliedVR also is deepening its clinical research around RelieVRx and is currently engaged in a 1,000-person health economics and outcomes research (HEOR) study. The company also is in talks with multiple commercial insurers to create reimbursement pathways and is exploring FDA label expansion to potentially treat more conditions.
AppliedVR is creating a new reality in healthcare. We are pioneering immersive therapeutics (ITx), a new category of medicine, to treat intractable health conditions that affect millions of people worldwide. Today, AppliedVR's treatments represent a robust approach to chronic lower back pain (CLBP) that empowers patients with an intuitive device they can self-manage at home. AppliedVR's RelieVRx™ program is the first VR-based, prescription therapeutic to receive Breakthrough Device Designation and De Novo authorization by the FDA for CLBP. AppliedVR's wellness programs have been trusted by more than 200 leading health systems and thousands of healthcare professionals globally, used on more than 60,000 patients. For more information, visit www.appliedvr.io.
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